Senior Manager, Head of Publishing Training - Regulatory Operations (Remote)
Senior Manager, Head of Publishing Training - Regulatory Operations (Remote)
United States - California - San Diego
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Job Title: Senior Manager, Head of Publishing Training - Regulatory Operations
Gilead is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
About the role:
This is an exciting opportunity to lead both major submissions and the training activities for our publishing group within North American Regulatory Operations. They will be creating and implementing new training methodologies, plans and remote training options globally with publishers, contractors and vendors.
- As a member of the Regulatory Operations team, this position is responsible for managing all aspects of training for our team's submission, compilation, and publishing activities associated with generating highly complex hard copy and electronic submissions within Regulatory Operations.
- May be the submission publishing lead for a specific therapeutic area: Coordinating complex logistical details associated with generating paper/electronic regulatory submissions, including identification and sourcing of submission content, project and timeline planning, oversight of publication activities, and set up and operation of document management, authoring, and publishing tools.
- Designs, develops, and implements training methodologies that have a positive impact on our team's culture while ensuring rapid learning of publishing skills from basic to complex.
- Oversees the development of highly effective remote training options for submission publishing.
- Coordinates with submission publishing managers to give and receive training feedback for their direct reports.
- Designs, develops, and implements submissions related training for cross-functional groups.
- Owns multiple projects. May review documentation for, and maintain oversight of, the status of all projects across the whole department.
- Interfaces with Regulatory Operations globally to ensure technologies, training, processes and required resources are in line with global Gilead business objectives. Follows and interprets FDA, EMEA and ICH guidelines for electronic submissions.
- Has overall responsibility for the successful completion of major initiatives.
- Represents the organization as the primary training contact for projects of any complexity.
- Directs highly complex logistical details associated with generating regulatory submissions. Participates in senior management's strategic development of plans in preparation for published regulatory submissions within given timelines.
- Works independently without appreciable direction and exercises considerable latitude in determining technical and business objectives and assignments.
- Communicates the status of ongoing projects to internal senior management and across functions as appropriate. Provides support for project roll-outs where necessary. Acts as internal stakeholder for projects and sits on steering teams as applicable.
- Support training related to company mergers and acquisitions for publishing.
- Performance management of direct reports, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings.
Knowledge & Skills:
- Must have excellent verbal, written, extensive organizational and time management skills and a strong attention to detail.
- Is able to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy customers.
- Must be able to direct and oversee work projects effectively within an environment that has quickly changing processes, priorities, and deadlines.
- Must have significant experience developing Submission Publishing internal and external training and a demonstrated interest in effective training methodologies.
- Must be able to streamline all processes from highly complex to routine to improve efficiency, productivity, and add value.
Education & Experience:
- 10+ years of relevant experience and a BA or BS.
- 8+ years of relevant experience and an MS.
- Extensive experience in Regulatory Publishing including leading NDA submissions is required.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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